Purpose: The success of foot-and-mouth disease (FMD) serological serosurveillance greatly depends on the FMD vaccine which does not include any non-structural proteins (NSPs) of the FMD virus. Since pure FMD vaccines from NSPs are used with the FMD eradication programs using DIVA (Differentiating Infected from Vaccinated Animals) tests. Apart from the in-vivo test defined in the World Organisation for Animal Health, two different test kits were developed in-process NSP detection purposes. The first test kit was developed in 2010 and the second one has been very recently developed in 2019.
Materials and methods: In this study, the level of NSP has been examined by first-chemiluminescent filtration assisted (FAL)-enzyme-linked immunosorbent assay (ELISA) based in-vitro, in-process test kit for Turkey FMD vaccine antigen samples. A total of 94 samples were used. The critical maximum acceptable levels of NSP were determined after purification stage of samples.
Results: As a maximum NSP level, 70 ng NSP for the polyethylene glycol concentrated samples and 30 ng NSP for the vaccine antigen mixture samples were accepted. A mini repeatability study was also performed. The correlation between the NSP, total protein, and 146S particul quantity of samples were analyzed.
Conclusion: As a conclusion, the chemiluminescent FAL-ELISA based test kit can be used for the NSP purity level determination of in-process samples.
Keywords: Determination; Foot-and-mouth disease; In-process; Non-structural protein; Vaccine.
© Korean Vaccine Society.